Oral MucosaNCT05219747
The Effectiveness and Safety of Mucoadhesive Film Containing A.Oleracea Extract
A study testing Mucoadhesive film containing Acmella oleracea extract and Mucoadhesive film without Acmella oleracea extract in people with Oral Mucosa, run by Khon Kaen University at 1 site in Thailand.
Trial summary
Several natural products have been use to promote wound healing and relieve pain. Acmella oleracea has a component that has anesthetic and anti-inflammatory properties. The mucoadhesive film can be improved by drug delivery system due to close contact with the absorption tissue leading to improvement in both local and… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Mucosa
- What is being tested?
- Mucoadhesive film containing Acmella oleracea extract and Mucoadhesive film without Acmella oleracea extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteThailand
- Study dates
- 28 Feb 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy people age 18-60 years old and do not have regular medication.
- Able to give the consent formation in a study and to cooperate in answering questionnaires or data records in google formation.
- The participants must not have any wounds, tattoos, inflammation or pathology on the oral mucosa and skin of testing area.
- The participants who can come to follow up for a specified period of time.
Who cannot join
- The participants who need dental treatment or necessary to use topical medication to treat oral diseases during the study period (7 days).
- History of allergic to the components of mucoadhesive film and/or have a history of other allergies.
- The vulnerable participants include pregnancy or lactating women and disabilities.
- History of using antihistamines drugs during the one-week period prior to joining the study or participants who need to use such antihistamines during the time participating in the study.
- History of using topical gluco-corticosteroids during the one-week period on skin testing areas.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness and Safety of Mucoadhesive Film Containing Acmella Oleracea Extract in Healthy Subjects: A Randomized Control Trial
Several natural products have been use to promote wound healing and relieve pain. Acmella oleracea has a component that has anesthetic and anti-inflammatory properties.
The mucoadhesive film can be improved by drug delivery system due to close contact with the absorption tissue leading to improvement in both local and systemic effects.
Read more
This study aims to evaluate the effectiveness and safety of mucoadhesive film containing Acmella oleracea extract in healthy subjects. This is a randomised, double-blind (participant and investigator), parallel-controlled clinical trial. In total, approximately 72 subjects will be enrolled into study.
Objectives
- To investigate the potential of skin allergy reaction to mucoadhesive film containing Acmella oleracea extract in healthy subjects
- To study the duration of mucosal adhesion of mucoadhesive film
- To study the local anesthetic effect, participant's satisfaction and adverse effect of mucoadhesive film containing Acmella oleracea extract
Read the detailed description
Total 72 Participants will divided into 2 groups by dentist who was not an examiner performed the randomization using blocked randomization (block of 4) from program of https://www.sealedenvelope.com/simple-randomiser/v1/lists/1. Study group will receive mucoadhesive film containing Acmella oleracea extract while control group will receive mucoadhesive film without active component. All participants in the study group will be test for allergic reaction of mucoadhesive film by skin prick test and patch skin test before testing and have to follow-up appointments (at 2, 4 and 7 days after skin test). At first visit, all participants will received oral examination and informed how to use mucoadhesive film by examiner. Then participants will asked to apply the mucoadhesive film at oral mucosa of lower lip. The effectiveness of intra-oral mucoadhesive film in this study will evaluated as follows :
- Duration of mucosal adhesion and adverse effect by self report
- The local anesthetic effect by using Numeric rating scale (NRS)
- Participant's satisfaction by using Numeric rating scale (NRS)
The statistical methods :
General and oral health data, duration of mucosal adhesion will reported as frequencies, percentages and means (Standard deviation). The different of NRS score between groups will analyzed Independent t- test or Mann-Whitney U test. Using SPSS software. Statistically significant will considered at p-value < 0.05.
- Conditions
- Oral Mucosa
- Being tested
- Mucoadhesive film containing Acmella oleracea extract, Mucoadhesive film without Acmella oleracea extract
- Keywords
- Mucoadhesive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mucoadhesive film containing Acmella oleracea extractOther
Participants will apply a mucoadhesive film containing Acmella oleracea extract on labial mucosa of lower lip by themselves at least for 2 hours
Mucoadhesive film without Acmella oleracea extractOther
Participants will apply a mucoadhesive film on labial mucosa of lower lip by themselves at least for 2 hours
| Study group | Role | What they receive |
|---|---|---|
| A.Oleracea group | Experimental | Mucoadhesive film containing Acmella oleracea extract Receives: Other: Mucoadhesive film containing Acmella oleracea extract |
| Placebo group | Placebo comparator | Mucoadhesive film without Acmella oleracea extract Receives: Other: Mucoadhesive film without Acmella oleracea extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the potential of skin allergy reaction to mucoadhesive film containing Acmella oleracea extract by skin prick test
Outcome will be a number of participants with skin allergic reaction assessed by skin prick test
Measured: Evaluate at 15 minutes after test in the 1st visit
To investigate the potential of skin allergy reaction to mucoadhesive film containing Acmella oleracea extract by patch skin test at 2nd day after test
Outcome will be a number of participants with skin allergic reaction assessed by patch skin test at 2nd day after test
Measured: Evaluate at 2 days after patch skin test application
To investigate the potential of skin allergy reaction to mucoadhesive film containing Acmella oleracea extract by patch skin test at 4th day after test
Outcome will be a number of participants with skin allergic reaction assessed by path skin test at 4th day after test.
Measured: Evaluate at 4th day after patch skin test application
To investigate the potential of skin allergy reaction to mucoadhesive film containing Acmella oleracea extract by patch skin test at 7th day after test
Outcome will be a number of participants with skin allergic reaction assessed by path skin test at 7th day after test.
Measured: Evaluate at 7th day after patch skin test application
To study the duration of mucosal adhesion of mucoadhesive film in healthy oral mucosa
Outcomes will be the duration in minutes of the mucoadhesive film adhering to participant' s oral mucosa
Measured: Self reporting the time at which the film detaches (e.g. 16.30 hr.), within 24 hours after mucoadhesive film application
To study the local anesthetic effect
Outcome will be a score of Numeric rating scale (NRS) of local anesthetic effect. On a scale of 0-10, where 0 = no anesthetic effect and 10 = completely anesthetize
Measured: Self reporting at 1st visit, at 3 and 5minutes after application
To study adverse effect related to mucoadhesive film use
Outcome will be a number of participants who have adverse effect and the symptom of adverse effect
Measured: Evaluate within 2 hours after mucoadhesive film application
To evaluate participant's satisfaction
Outcome will be a score of Numeric rating scale (NRS) of satisfaction of mucoadhesive film use. On a scale of 0-10, where 0 = totally unsatisfied and 10 = the most satisfied
Measured: Evaluate at 2 hours after mucoadhesive film application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start28 Feb 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomize control trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kemporn Kitsahawong, Khon Kaen University
- Investigators
- Kemporn Kitsahawong, DDS,MSc,PhD, Principal investigator, Faculty of Dentistry, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219747
- Sponsor's protocol ID
- KKUHE641398
- Status last verified
- Dec 2021
- First submitted
- 1 Dec 2021
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Mucoadhesive Film Containing Acmella Oleracea Extract in Healthy Subjects: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05219747
- Acronym / sponsor ID
- KKUHE641398
- Conditions
- Oral Mucosa
- Keywords
- Mucoadhesive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 28 Feb 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Several natural products have been use to promote wound healing and relieve pain. Acmella oleracea has a component that has anesthetic and anti-inflammatory properties.
The mucoadhesive film can be improved by drug delivery system due to close contact with the absorption tissue leading to improvement in both local and systemic effects.
This study aims to evaluate the effectiveness and safety of mucoadhesive film containing Acmella oleracea extract in healthy subjects. This is a randomised, double-blind (participant and investigator), parallel-controlled clinical trial. In total, approximately 72 subjects will be enrolled into study.
Objectives
- To investigate the potential of skin allergy reaction to mucoadhesive film containing Acmella oleracea extract in healthy subjects
- To study the duration of mucosal adhesion of mucoadhesive film
- To study the local anesthetic effect, participant's satisfaction and adverse effect of mucoadhesive film containing Acmella oleracea extract
Detailed description
Total 72 Participants will divided into 2 groups by dentist who was not an examiner performed the randomization using blocked randomization (block of 4) from program of https://www.sealedenvelope.com/simple-randomiser/v1/lists/1. Study group will receive mucoadhesive film containing Acmella oleracea extract while control group will receive mucoadhesive film without active component. All participants in the study group will be test for allergic reaction of mucoadhesive film by skin prick test and patch skin test before testing and have to follow-up appointments (at 2, 4 and 7 days after skin test). At first visit, all participants will received oral examination and informed how to use mucoadhesive film by examiner. Then participants will asked to apply the mucoadhesive film at oral mucosa of lower lip. The effectiveness of intra-oral mucoadhesive film in this study will evaluated as follows :
- Duration of mucosal adhesion and adverse effect by self report
- The local anesthetic effect by using Numeric rating scale (NRS)
- Participant's satisfaction by using Numeric rating scale (NRS)
The statistical methods :
General and oral health data, duration of mucosal adhesion will reported as frequencies, percentages and means (Standard deviation). The different of NRS score between groups will analyzed Independent t- test or Mann-Whitney U test. Using SPSS software. Statistically significant will considered at p-value < 0.05.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomize control trial
| Arm | Type | Receives |
|---|---|---|
| A.Oleracea group | Experimental | Other: Mucoadhesive film containing Acmella oleracea extractMucoadhesive film containing Acmella oleracea extract |
| Placebo group | Placebo comparator | Other: Mucoadhesive film without Acmella oleracea extractMucoadhesive film without Acmella oleracea extract |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy people age 18-60 years old and do not have regular medication.
- Able to give the consent formation in a study and to cooperate in answering questionnaires or data records in google formation.
- The participants must not have any wounds, tattoos, inflammation or pathology on the oral mucosa and skin of testing area.
- The participants who can come to follow up for a specified period of time.
Key exclusion criteria (5 listed)
- The participants who need dental treatment or necessary to use topical medication to treat oral diseases during the study period (7 days).
- History of allergic to the components of mucoadhesive film and/or have a history of other allergies.
- The vulnerable participants include pregnancy or lactating women and disabilities.
- History of using antihistamines drugs during the one-week period prior to joining the study or participants who need to use such antihistamines during the time participating in the study.
- History of using topical gluco-corticosteroids during the one-week period on skin testing areas.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mucoadhesive film containing Acmella oleracea extractParticipants will apply a mucoadhesive film containing Acmella oleracea extract on labial mucosa of lower lip by themselves at least for 2 hours | Other | A.Oleracea group |
| Mucoadhesive film without Acmella oleracea extractParticipants will apply a mucoadhesive film on labial mucosa of lower lip by themselves at least for 2 hours | Other | Placebo group |
Primary outcome
To investigate the potential of skin allergy reaction to mucoadhesive film containing Acmella oleracea extract by skin prick test
Time frame: Evaluate at 15 minutes after test in the 1st visit
Outcome will be a number of participants with skin allergic reaction assessed by skin prick test
To investigate the potential of skin allergy reaction to mucoadhesive film containing Acmella oleracea extract by patch skin test at 2nd day after test
Time frame: Evaluate at 2 days after patch skin test application
Outcome will be a number of participants with skin allergic reaction assessed by patch skin test at 2nd day after test
To investigate the potential of skin allergy reaction to mucoadhesive film containing Acmella oleracea extract by patch skin test at 4th day after test
Time frame: Evaluate at 4th day after patch skin test application
Outcome will be a number of participants with skin allergic reaction assessed by path skin test at 4th day after test.
To investigate the potential of skin allergy reaction to mucoadhesive film containing Acmella oleracea extract by patch skin test at 7th day after test
Time frame: Evaluate at 7th day after patch skin test application
Outcome will be a number of participants with skin allergic reaction assessed by path skin test at 7th day after test.
To study the duration of mucosal adhesion of mucoadhesive film in healthy oral mucosa
Time frame: Self reporting the time at which the film detaches (e.g. 16.30 hr.), within 24 hours after mucoadhesive film application
Outcomes will be the duration in minutes of the mucoadhesive film adhering to participant' s oral mucosa
To study the local anesthetic effect
Time frame: Self reporting at 1st visit, at 3 and 5minutes after application
Outcome will be a score of Numeric rating scale (NRS) of local anesthetic effect. On a scale of 0-10, where 0 = no anesthetic effect and 10 = completely anesthetize
To study adverse effect related to mucoadhesive film use
Time frame: Evaluate within 2 hours after mucoadhesive film application
Outcome will be a number of participants who have adverse effect and the symptom of adverse effect
To evaluate participant's satisfaction
Time frame: Evaluate at 2 hours after mucoadhesive film application
Outcome will be a score of Numeric rating scale (NRS) of satisfaction of mucoadhesive film use. On a scale of 0-10, where 0 = totally unsatisfied and 10 = the most satisfied
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Oral Mucosa
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
Not yet recruitingObservational study
Oral Mucosal Grafting for Nasal Septal Perforation Repair
Nasal Septal Perforation
RecruitingObservational study
Biospecimen Procurement for Head and Neck Disorders
Hearing Disorder, Oral Mucosal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kemporn Kitsahawong, DDS,MSc,PhD principal investigator
Faculty of Dentistry, Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mucoadhesive film containing Acmella oleracea extract and Mucoadhesive film without Acmella oleracea extract in people with Oral Mucosa, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kemporn Kitsahawong, DDS,MSc,PhD (0910566996, kkempo@kku.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the potential of skin allergy reaction to mucoadhesive film containing Acmella oleracea extract by skin prick test (time frame: Evaluate at 15 minutes after test in the 1st visit). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.